Omeros: FDA Agrees With OMS302 Pediatric Study Plan - Quick Facts

(RTTNews) - Omeros Corp. (OMER) announced the U.S. FDA has confirmed its agreement with the Pediatric Study Plan proposed by the company to study the use of OMS302 in pediatric patients undergoing primary cataract extraction. Omeros said FDA has also issued a written request consistent with the PSP, which means that successful completion of the PSP would make OMS302 eligible for an additional six months of marketing exclusivity in the U.S.

OMS302 is Omeros' product being developed for use during intraocular lens replacement, including cataract surgery and refractive lens exchange. OMS302 is a proprietary combination of the mydriatic (pupil dilating) agent phenylephrine and the anti-inflammatory agent ketorolac. Omeros' NDA for OMS302 has been accepted for filing by the FDA and its MAA for OMS302 has been validated by the EMA.